HOUSE BILL NO. 1717 103RD GENERAL ASSEMBLY
INTRODUCED BY REPRESENTATIVE WEST.
4914H.01I JOSEPH ENGLER, Chief Clerk
AN ACT To repeal section 191.480, RSMo, and to enact in lieu thereof three new sections relating to alternative therapies.
Be it enacted by the General Assembly of the state of Missouri, as follows:
Section A. Section 191.480, RSMo, is repealed and three new sections enacted in lieu 2 thereof, to be known as sections 191.479, 191.480, and 630.1170, to read as follows: 191.479. 1. As used in this section, the following terms mean: 2 (1) "Bona fide physician-patient relationship", a relationship between a 3 physician and a patient in which the physician: 4 (a) Has completed an assessment of the patient's medical history and current 5 medical condition, including an in-person examination of the patient; 6 (b) Has consulted with the patient with respect to the patient's medical 7 condition; and 8 (c) Is available to provide follow-up care and treatment to the patient; 9 (2) "Facilitator", an individual who is present with a person who uses psilocybin 10 in order to facilitate the therapeutic use of the psilocybin for the person; 11 (3) "Veteran", any person defined as a veteran by the United States Department 12 of Veterans Affairs or its successor agency. 13 2. Notwithstanding the provisions of chapter 195 or 579 or any other provision of 14 law to the contrary, any person who acquires, uses, produces, possesses, transfers, or 15 administers psilocybin for the person's own therapeutic use shall not be in violation of 16 state or local law and shall not be subject to a civil fine, penalty, or sanction so long as 17 the following conditions are met:
EXPLANATION — Matter enclosed in bold-faced brackets [thus] in the above bill is not enacted and is intended to be omitted from the law. Matter in bold-face type in the above bill is proposed language. HB 1717 2
18 (1) The person is a veteran who is twenty-one years of age or older; 19 (2) The person suffers from posttraumatic stress disorder, major depressive 20 disorder, or a substance use disorder or requires end-of-life care; 21 (3) The person has enrolled in a study on the use of psilocybin to treat 22 posttraumatic stress disorder, major depressive disorder, or substance use disorders or 23 for end-of-life care; 24 (4) The person informs the department of mental health that the person plans to 25 acquire, use, produce, possess, transfer, or administer psilocybin in accordance with this 26 section; 27 (5) The person provides the department of mental health with: 28 (a) Documentation from a physician with whom the patient has a bona fide 29 physician-patient relationship that the person suffers from posttraumatic stress 30 disorder, major depressive disorder, or a substance use disorder or requires end-of- 31 life care; 32 (b) The name of the individual who will serve as the person's facilitator; 33 (c) The address of the location where the use of psilocybin will take place; and 34 (d) The time period, not to exceed twelve months, during which the person will 35 use psilocybin; 36 (6) The person's use of psilocybin occurs only in the presence of a facilitator who 37 meets the following requirements: 38 (a) Is: 39 a. A licensed physician; 40 b. A licensed mental health professional who earned a doctor of psychology 41 degree or a doctor of philosophy degree in psychology; 42 c. A mental health therapist who has a master's degree in a relevant field and 43 who has full clinical licensure including, but not limited to, a licensed clinical social 44 worker, a licensed marital and family therapist, a licensed professional counselor, or an 45 art therapist; 46 d. A licensed nurse who holds a doctorate in nursing practice; 47 e. A licensed physician assistant; 48 f. A psychiatric mental health nurse practitioner; or 49 g. A licensed advanced practice registered nurse; 50 (b) Has completed a training program that is specific to psilocybin and that: 51 a. Is consistent with the current professional practice guidelines for psychedelic- 52 assisted therapy published by the American Psychological Association or the American 53 Psychedelic Practitioners Association and complies with each such guideline; HB 1717 3
54 b. Covers all content areas set forth in the professional practice guidelines of the 55 American Psychological Association or the American Psychedelic Practitioners 56 Association; and 57 c. Consists of at least thirty hours of synchronous learning; 58 (c) Except for psychiatrists, psychiatric mental health nurse practitioners, and 59 holders of a doctorate degree in psychology, completes ninety minutes of continuing 60 education on the Diagnostic and Statistical Manual of Mental Disorders before serving 61 as a facilitator for any person and during each relevant licensure renewal period; and 62 (d) Has received training in end-of-life care or in one or more of the following 63 diagnostic categories: 64 a. Posttraumatic stress disorder; 65 b. Complex posttraumatic stress disorder; 66 c. Major depressive disorder; or 67 d. Substance use disorder; 68 (7) The person ensures that a laboratory licensed by the state to test controlled 69 substances tests the psilocybin the person intends to ingest; and 70 (8) The person limits the use of psilocybin to no more than one hundred fifty 71 milligrams of psilocybin analyte (4-phosphoryloxy-N, N-dimethyltryptamine) during 72 any twelve-month period. 73 3. Notwithstanding the provisions of chapter 195 or 579 or any other provision of 74 law to the contrary: 75 (1) Any person twenty-one years of age or older who assists another person in 76 any of the acts allowed under subsection 2 of this section shall not be in violation of state 77 or local law and shall not be subject to a civil fine, penalty, or sanction; and 78 (2) Any laboratory licensed by the state to test controlled substances or cannabis 79 that tests psilocybin for a person engaged in acts allowed under subsection 2 of this 80 section shall not be in violation of state or local law and shall not be subject to a civil 81 fine, penalty, or sanction. 82 4. Subject to appropriation, the department of mental health shall provide 83 grants totaling two million dollars for research on the use and efficacy of psilocybin for 84 persons described in subsection 2 of this section. 85 5. The department of mental health shall prepare and submit to the governor, 86 lieutenant governor, and the general assembly annual reports on any information 87 collected by the department on the implementation and outcomes of the use of 88 psilocybin as described in subsection 2 of this section. HB 1717 4
89 6. The department of mental health shall maintain the confidentiality of any 90 personally identifiable protected information collected from any persons who provide 91 information to the department under subsection 2 of this section. 92 7. Notwithstanding any other provision of law to the contrary, the department of 93 mental health, any health care providers, and any other person involved in the acts 94 described in subsection 2 of this section shall not be subject to criminal or civil liability 95 or sanction under the laws of this state for providing care to a person engaged in acts 96 allowed under subsection 2 of this section, except in cases of gross negligence or willful 97 misconduct. No health care provider shall be subject to discipline against his or her 98 professional license for providing care to a person engaged in acts allowed under 99 subsection 2 of this section. 100 8. Notwithstanding any other provision of law to the contrary, a physician shall 101 not be subject to criminal or civil liability or sanction under the laws of this state for 102 providing documentation that a person suffers from posttraumatic stress disorder, 103 major depressive disorder, or a substance use disorder or requires end-of-life care, and 104 no state agency or regulatory board shall revoke, fail to renew, or take any other action 105 against a physician's license issued under chapter 334 based solely on the physician's 106 provision of documentation that a person suffers from posttraumatic stress disorder, 107 major depressive disorder, or a substance use disorder or requires end-of-life care. 108 9. Notwithstanding any other provision of law to the contrary, no state agency or 109 employee of a state agency shall disclose to the federal government, any federal 110 government employee, or any unauthorized third party the statewide list or any 111 individual information of persons who meet the requirements of this section. 191.480. 1. For purposes of this section, the following terms shall mean: 2 (1) "Eligible patient", a person who meets all of the following: 3 (a) Has a terminal condition or illness, a life-threatening condition or illness, or a 4 severely debilitating condition or illness; 5 (b) Has considered all other treatment options currently approved by the United 6 States Food and Drug Administration and all relevant clinical trials conducted in this state; 7 (c) Has received a prescription or recommendation from the person's physician for an 8 investigational drug, biological product, or device; 9 (d) Has given written informed consent which shall be at least as comprehensive as 10 the consent used in clinical trials for the use of the investigational drug, biological product, or 11 device or, if the patient is a minor or lacks the mental capacity to provide informed consent, a 12 parent or legal guardian has given written informed consent on the patient's behalf; and 13 (e) Has documentation from the person's physician that the person has met the 14 requirements of this subdivision; HB 1717 5
15 (2) "Investigational drug, biological product, or device", a drug, biological product, or 16 device, any of which are used to treat the patient's terminal condition or illness, life- 17 threatening condition or illness, or severely debilitating condition or illness, that has 18 successfully completed phase one of a clinical trial but has not been approved for general use 19 by the United States Food and Drug Administration and remains under investigation in a 20 clinical trial[. The term shall not include Schedule I controlled substances]; 21 (3) "Life-threatening condition or illness", a disease or condition: 22 (a) In which the likelihood of death is high unless the course of the disease is 23 interrupted; and 24 (b) With potentially fatal outcomes, where the end point of clinical trial analysis 25 is survival; 26 (4) "Severely debilitating condition or illness", a disease or condition that causes 27 major irreversible morbidity; 28 (5) "Terminal condition or illness", a disease or condition that without life- 29 sustaining procedures will result in death in the near future or a state of permanent 30 unconsciousness from which recovery is unlikely. 31 2. A manufacturer of an investigational drug, biological product, or device may make 32 available the manufacturer's investigational drug, biological product, or device to eligible 33 patients under this section. This section does not require that a manufacturer make available 34 an investigational drug, biological product, or device to an eligible patient. A manufacturer 35 may: 36 (1) Provide an investigational drug, biological product, or device to an eligible patient 37 without receiving compensation; or 38 (2) Require an eligible patient to pay the costs of or associated with the manufacture 39 of the investigational drug, biological product, or device. 40 3. This section does not require a health care insurer to provide coverage for the cost 41 of any investigational drug, biological product, or device. A health care insurer may provide 42 coverage for an investigational drug, biological product, or device. 43 4. This section does not require the department of corrections to provide coverage for 44 the cost of any investigational drug, biological product, or device. 45 5. Notwithstanding any other provision of law to the contrary, no state agency or 46 regulatory board shall revoke, fail to renew, or take any other action against a physician's 47 license issued under chapter 334 based solely on the physician's recommendation to an 48 eligible patient regarding prescription for or treatment with an investigational drug, biological 49 product, or device. Action against a health care provider's Medicare certification based solely 50 on the health care provider's recommendation that a patient have access to an investigational 51 drug, biological product, or device is prohibited. HB 1717 6
52 6. If a provision of this section or its application to any person or circumstance is held 53 invalid, the invalidity does not affect other provisions or applications of this section that can 54 be given effect without the invalid provision or application, and to this end the provisions of 55 this section are severable. 56 7. If the clinical trial is closed due to lack of efficacy or toxicity, the drug shall not be 57 offered. If notice is given on a drug, product, or device taken by a patient outside of a clinical 58 trial, the pharmaceutical company or patient's physician shall notify the patient of the 59 information from the safety committee of the clinical trial. 60 8. Except in the case of gross negligence or willful misconduct, any person who 61 manufactures, imports, distributes, prescribes, dispenses, or administers an investigational 62 drug or device to an eligible patient [with a terminal illness] in accordance with this section 63 shall not be liable in any action under state law for any loss, damage, or injury arising out of, 64 relating to, or resulting from: 65 (1) The design, development, clinical testing and investigation, manufacturing, 66 labeling, distribution, sale, purchase, donation, dispensing, prescription, administration, or 67 use of the drug or device; or 68 (2) The safety or effectiveness of the drug or device. 630.1170. 1. Notwithstanding the provisions of chapter 195 or 579 to the 2 contrary, the department of mental health, in collaboration with a hospital operated by 3 an institution of higher education in this state or with contract research organizations 4 conducting studies approved by the United States Food and Drug Administration, shall 5 conduct a study on the efficacy of using alternative medicine and therapies, including 6 the use of psilocybin, in the treatment of veterans who suffer from posttraumatic stress 7 disorder, major depressive disorder, or substance use disorders or who require end-of- 8 life care. 9 2. (1) In conducting the study, the department of mental health, in collaboration 10 with the hospital or contract research organizations described in subsection 1 of this 11 section and subject to appropriations, shall: 12 (a) Perform a study on the therapeutic efficacy of using psilocybin in the 13 treatment of veterans who suffer from posttraumatic stress disorder, major depressive 14 disorder, or substance use disorders or who require end-of-life care; and 15 (b) Review current literature regarding: 16 a. The safety and efficacy of psilocybin in the treatment of veterans who suffer 17 from posttraumatic stress disorder, major depressive disorder, or substance use 18 disorders or who require end-of-life care; and 19 b. The access that veterans have to psilocybin for such treatment. HB 1717 7
20 (2) The department of mental health shall prepare and submit to the governor, 21 lieutenant governor, and the general assembly the following: 22 (a) Quarterly reports on the progress of the study; and 23 (b) A written report, submitted one year following the commencement of the 24 study, that shall: 25 a. Contain the results of the study and any recommendations for legislative or 26 regulatory action; and 27 b. Highlight those clinical practices that appear to be most successful as well as 28 any safety or health concerns. 29 3. The department of mental health shall maintain the confidentiality of any 30 personally identifiable protected information collected during the study under this 31 section. 32 4. Notwithstanding any other provision of law to the contrary, the department of 33 mental health, any health care providers, and any other person involved in the study 34 under this section shall not be subject to criminal or civil liability or sanction under the 35 laws of this state for participating in the study, except in cases of gross negligence or 36 willful misconduct. No health care provider shall be subject to discipline against his or 37 her professional license for participation in the study. 38 5. Notwithstanding any other provision of law to the contrary, a physician shall 39 not be subject to criminal or civil liability or sanction under the laws of this state for 40 referring a veteran to the study under this section, and no state agency or regulatory 41 board shall revoke, fail to renew, or take any other action against a physician's license 42 issued under chapter 334 based solely on the physician's referral of a veteran to the 43 study under this section. ✔
Statutes affected: